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Muscle Function Assessment for Postpartum Women

N/A

Recruiting

Led By Bryan Heiderscheit, PT, DPT, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 days

Awards & highlights

Study Summary

This trial will study how well a woman can control her lower body and trunk muscles after giving birth, as well as how active she is. There will be two sessions, a week apart, to test this.

Who is the study for?

This trial is for women who have recently given birth to their first child and are experiencing muscle weakness or fatigue. They should not be on daily anti-inflammatory/pain medications, have significant orthopedic conditions, previous abdominal surgeries (except Cesarean), or any neuromuscular health issues.Check my eligibility

What is being tested?

The study will use ultrasound imaging and various physical tests to assess the muscle function of the lower body and abdomen in new mothers. Participants will attend two sessions about a week apart to measure their neuromuscular control.See study design

What are the potential side effects?

There may be minimal side effects from this study as it involves non-invasive testing such as ultrasound imaging and physical strength assessments. However, some discomfort during testing due to exertion might occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Abdominal Fascial Integrity Measured by Mean Inter-Recti Distance

Incidence of Lumbopelvic Instability

Incidence of Perceived Difficulty with ASLR Task

+5 more

Secondary outcome measures

Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Pain Score

Assessment of fatigability of the lumbopelvic stabilizing muscles measured by the ASLR Fatigue Task: Mean Ratings of Perceived Exertion (RPE)

Average Minutes per Day of Activity in at least 10-minute bouts

+15 more

Other outcome measures

Mean discharge rate of single motor units

Percent of Maximum Voluntary Isometric Contraction (MVIC)

Root mean square (RMS) of global EMG

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PostpartumExperimental Treatment4 Interventions

Participants who are six months postpartum will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless Electromyography (EMG) sensors will be used to record EMG and limb steadiness (via Inertial Measurement Units (IMU). Physical activity will be measured by questionnaire and accelerometer.

Group II: NulligravidActive Control4 Interventions

Participants who have never been pregnant will complete 2 experimental sessions, separated by 7-10 days. Participants will complete multiple questionnaires, maximal voluntary contractions of the lower extremity muscles, clinical tests of lumbopelvic neuromuscular control/posterior pelvic pain provocation, and fatiguing lower extremity/trunk muscle exercise. Ultrasound imaging will be performed to measure inter-recti distance. Wireless EMG sensors will be used to record EMG and limb steadiness (via IMUs). Physical activity will be measured by questionnaire and accelerometer.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,184 Previous Clinical Trials

3,169,493 Total Patients Enrolled

1 Trials studying Muscle Weakness

80 Patients Enrolled for Muscle Weakness

Carroll UniversityOTHER

Bryan Heiderscheit, PT, DPT, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Active Straight Leg Raise Fatigue Task Clinical Trial Eligibility Overview. Trial Name: NCT05073224 — N/A

Muscle Weakness Research Study Groups: Postpartum, Nulligravid

Muscle Weakness Clinical Trial 2023: Active Straight Leg Raise Fatigue Task Highlights & Side Effects. Trial Name: NCT05073224 — N/A

Active Straight Leg Raise Fatigue Task 2023 Treatment Timeline for Medical Study. Trial Name: NCT05073224 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count of this clinical trial?

"Affirmative. The information on clinicaltrials.gov signals that this research is actively seeking participants, with 78 patients sought from two different locations since the trial's inception on September 20th 2022 (with updates as recent as September 21st)."

Answered by AI

Are there any vacant positions in this research endeavor?

"Per the clinicaltrials.gov listing, this trial is presently enrolling patients and has been since September 20th 2022. The most recent update was made on the 21st of that same month."

Answered by AI

What objectives are researchers attempting to accomplish with this clinical investigation?

"The primary aim of this 10-day trial is to ascertain the Maximum Lower Extremity Strength: Leg. Additionally, secondary objectives include analysing Average Minutes per Day of Activity in at least 10 minutes bouts with a triaxial accelerometer; measuring Mean Global Pittsburgh Sleep Quality Index (PSQI) Score scores and the Assessment of fatigability of lumbopelvic stabilizing muscles through an ASLR Fatigue Task that evaluates Pain Scores on a 0-10 scale every 30-60 seconds."

Answered by AI

Is eligibility for this clinical trial restricted to individuals over the age of 40?

"This trial is specifically seeking out participants aged 20 to 35. Additionally, there are 12 studies open for individuals below the age of 18 and 62 trials available for those over 65."

Answered by AI

Who is the optimal demographic for this medical experiment?

"This experiment is open to 78 individuals between the ages of 20 and 35 who suffer from muscle weakness. To be eligible, applicants must have recently given birth (post-partum) and this must be their first child (primiparous)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Muscle Function After Childbirth

2022. "Muscle Function After Childbirth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05073224.